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Sub-study of the Essen Study Centre for the ENTAiER Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04532073
Recruitment Status : Not yet recruiting
First Posted : August 31, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborators:
Software AG Stiftung
Universität Freiburg
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen

Brief Summary:

The present study is a sub-study of the ENTAiER study. The ENTAiER study is a multicenter, randomized, controlled study to evaluate the efficacy and safety of eurythmy therapy and Tai Chi in comparison to standard care in chronically ill older patients with an increased risk of falling.

In addition to the main questions of the ENTAiER study, three additional questions are being investigated at the Hospital Essen-Steele: Proteome and telomere analyses as well as qualitative parameters are recorded and examined. The aim is to compare the changes in proteomes, telomeres and qualitative factors under eurythmy therapy, Tai Chi and standard care in chronically ill older patients with an increased risk of falling.


Condition or disease Intervention/treatment Phase
Elderly Patients Chronically Ill Increased Risk of Falling Other: Eurythmy Therapy Other: Tai Chi Other: Standard Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sub-study of the Essen Study Centre With Proteome and Telomer Analyses and Qualitative Parameters for the ENTAiER Trial
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: Eurythmy therapy exercises
As part of the ENTAiER trial: In group sessions á 5 patients with a qualified therapist: In the first 3 months twice a week, in the second 3 months once a week. Recommendation to practice at home on at least 3 days per week (optimal, practice daily). They are supported by an eurythmy manual and an exercise video. This supplements the regular care.
Other: Eurythmy Therapy
A mindfulness-oriented movement therapy

Experimental: Tai Chi exercises
As part of the ENTAiER trial:In group sessions of 5 patients each with a qualified teacher: In the first 3 months twice a week, in the second 3 months once a week. Recommendation to practice at home on at least 3 days per week (optimal, practice daily). They are supported by a Tai Chi Manual and an exercise video. This complements the regular care
Other: Tai Chi
A martial art developed in China, which in recent times is often regarded as a system of movement theory or gymnastics

Active Comparator: Standard Care Only

As part of the ENTAiER trial:Brochure with detailed description of various evidence-based measures for fall prevention, prepared for the specific age group (https://www.trittsicher.org/files/trittsicher_bzga_sturzpraevention_2015-11-23.pdf)

- Recommendation to visit the family doctor and discuss fall prophylaxis with her

Other: Standard Care
Treatment process that a clinician should follow for a certain type of patient




Primary Outcome Measures :
  1. Change in proteomic analysis from baseline to after intervention [ Time Frame: Before intervention (week 0) and after intervention (6 months) ]
    A maximum of 500 µL plasma is used for the proteomic studies. The proteins are digested tryptically, a concentration determination is performed by amino acid analysis and the peptide samples are then measured by different mass spectrometric methods (data dependent (DDA) and independent detection (DIA), proteome-wide prediction of peptide tandem mass spectra by deep learning (Prosit), etc.). The results obtained are then verified by Western blot, ELISA and/or a targeted mass spectrometric method (parallel reaction monitoring)

  2. Change in telomer analysis from baseline to after intervention [ Time Frame: Before intervention (week 0) and after intervention (6 months) ]
    The telomere length is determined from blood samples using quantitative real-time PCR (TaqMan) from genomic DNA.

  3. Qualitative parameter [ Time Frame: After intervention (6 months) ]
    By means of semi-structured interviews of maximum 60 minutes per participant, the effects of the intervention are to be recorded qualitatively.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 65 years.
  • Chronic disease (musculoskeletal, neurological, internal medicine).
  • Increased risk of falling (Berg Balance Scale Score 49 or less).
  • Medical history: feeling of balance disturbance in the past.
  • Independent living at home or in an old people's or retirement home.
  • Regular participation in a one-hour event is possible.
  • Sufficiently mobile to leave the place of residence independently at least twice a week
  • Written declaration of consent.

Exclusion Criteria:

  • Disease that restricts participation (e.g. terminal disease, heart failure NYHA III-IV, unstable angina pectoris, uncontrolled seizure disorder, decompensated lung disease that already leads to shortness of breath during light activity, advanced cancer, chemo- or radiotherapy ongoing or during the last 3 months, amputation of one or both legs)
  • Complete dependence on the rollator.
  • Visual, hearing or speech problems that limit the understanding of the study documents and processes.
  • Major cognitive impairment (MoCA score 18 or less).
  • High risk of needing individual supervision during group sessions.
  • Severe personality disorder or psychiatric illness, alcoholism or other substance dependence affecting the group sessions.
  • Life expectancy under 1 year.
  • Permanent bed-riddenness expected in less than one year.
  • Regular participation in Tai Chi or EYT in the last 6 months.
  • Participation in intensive sports activities in the last month (e.g. training in the fitness centre or in sports groups which lead to breathlessness and sweating; skiing, mountaineering in high mountains).
  • Patients who cannot understand the nature, meaning and necessities of participating in a study.
  • Participation in another clinical trial within 3 months prior to screening for the ENTAiER trial or concurrent participation in another trial that may interfere with this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532073


Contacts
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Contact: Holger Cramer, PD Dr. +4920117425015 h.cramer@kem-med.com
Contact: Anna K Koch, Dr. +4920117425115 a.koch@kem-med.com

Sponsors and Collaborators
Universität Duisburg-Essen
Software AG Stiftung
Universität Freiburg
Additional Information:
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Responsible Party: Holger Cramer, Research Director, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT04532073    
Other Study ID Numbers: 20-9421-BO
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes